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Hill et al. [163] compared the costs of urine electrophoretic tests with sFLC immunoassays in routine screening. On a per-patient basis, costs increased by £4.73 if sFLC tests were used. However, this figure compared sFLC analysis in 100% of the patients with urine analysis in only 40% (due to poor compliance). Furthermore, savings made due to the reduction of time spent interpreting urine electrophoresis gels were unquantified and the authors concluded in favour of sFLC analysis, as better clinical governance was achieved with more clinical diagnoses. Potential organisational benefits, through replacing urine electrophoresis with sFLC assays, were also identified at the Christie Hospital, Manchester, UK; this study considered monitoring as well as screening and the data is presented in Section 24.10. The combination of CZE plus sFLC (e.g. Bakshi et al. [501], Holding et al. [188], Vermeersch et al. [505]) gives the opportunity of a more automated screening procedure, and may further reduce operating costs.

McTaggart et al. [508] noted that testing all patients for FLC production by urine analysis would require more staff than currently employed, whereas 100% testing with sFLC analysis did not require extra staff as the technique was less labour-intensive. Fulton and Fernando [506] reached similar conclusions in their review of screening strategies, and suggested that incorporation of sFLC analysis in the screening algorithm could reduce the volume of “labour-intensive” sIFE and urine electrophoresis while still increasing the detection of monoclonal proteins.

Katzmann et al. [499] compared the costs of sFLC screening with urine testing in the USA. The 2006 Medicare reimbursement for sFLCs was $38 compared with $71 for urine assays (total protein, UPE and uIFE). As sFLC tests cost approximately half that of urine tests, considerable laboratory savings could be made. Zia & Singh [512] reviewed testing patterns from an inner-city hospital in Midwestern USA (2009-2012) and found that costs could be reduced in spite of increased sFLC testing by more selective use of sIFE and UPEP/uIFE analysis.

Direct assessments of clinical cost benefits are difficult to make. However, one relatively simple clinical situation that may benefit by measuring sFLCs is the determination of underlying pathology in patients presenting with acute kidney injury (Chapter 27). If MM is suspected, the normal procedure has been to perform SPE/IFE and UPE. A simpler and better approach would be to perform SPE and sFLCs, which provides a rapid screen for monoclonal disease. Early diagnosis is essential in these patients and would allow the prompt initiation of disease-specific treatment and prevent irreversible renal damage and the need for long-term dialysis [165]. Data from a health economics study of this particular diagnostic issue has now been published by Cook et al. [513] who reported that there were economic gains (for the use of SPE + Freelite®) at both diagnostic and treatment stages. The use of sFLC analysis reduced the time to diagnosis and treatment and thereby improved the probability of both renal recovery and survival.

Wu et al. [989] developed an economic model to assess the impact of a typical American hospital changing their current practice to screen for MM to the algorithm recommended in national guidelines (NCCN Guidelines V.3.2017, Section 25.8). Such guidelines recommend the use of sFLC assays, along with SPE and sIFE to screen for MM and related plasma cell disorders. The model considered a typical hospital that was estimated to screen 967 patients MM per year. It predicted that guideline compliance would result in both a reduction in the time to MM diagnosis (from 159 days to 45 days) and an increase in the number of correct MM diagnoses (from 949 to 967 per year). Although hospital laboratories would expect to invest an additional $37,680 in diagnostic costs per year, this would be offset by the hospital saving $74,135 annually in averted complications resulting from earlier diagnosis. The authors conclude compliance with guidelines to screen for MM can help reduce costs, improve patient outcomes and increase efficiency of care.

Questions

How do sFLC assays fit into routine testing for monoclonal proteins?

When should urine electrophoresis still be included in a monoclonal gammopathy screening algorithm?